Healthcare Workforce Well-BeingNCT07791563
Digital Intervention for Healthcare Workers
A study testing Engage and HCW-Tailored Engage in people with Healthcare Workforce Well-Being, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to test which engagement strategies lead to more participation in a digital mental health program among healthcare workers. The main questions it aims to answer is: Does content tailoring increase engagement with the digital program? Does human support increase engagement with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Workforce Well-Being
- What is being tested?
- Engage and HCW-Tailored Engage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, all sexes
- Currently working in healthcare in the US with at least 4 hours per week of direct patient contact
- Stable access to internet
- Have a total score between 3-14 on the PHQ-9 (Patient Health Questionnaire-9), suggestive of mild to moderate depressive symptoms
Who cannot join
- Have a total score of ≥15 on the PHQ-9, indicating Severe Depressive symptoms.
- Currently diagnosed with a psychotic disorder or bipolar disorder, based on self-report.
- Currently receiving psychotherapy for depression or anxiety based on self-report; If on medications for depression or anxiety, must be on a stable dose of medication for at least 2 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Neuropsychiatric Institute
Chicago, Illinois, 60612
Jennifer Duffecy, PhD, 312-413-1225, jduffecy@uic.edu
About this study
Official title: Enhancing Sustained Engagement in Digital Mental Health Interventions (DMHIs)
The goal of this clinical trial is to test which engagement strategies lead to more participation in a digital mental health program among healthcare workers. The main questions it aims to answer is:
- Does content tailoring increase engagement with the digital program?
- Does human support increase engagement with the digital program?
Read more
Researchers will compare the general intervention to a tailored intervention and to the tailored intervention with human support coaching to see what leads to more engagement with/use of the program.
Participants will:
- Use a digital program weekly for 6 weeks
- Complete questionnaires at 5 times: Start of study, Week 2, Week 3 (mid-program), Week 6 (end of program), and Week 10 (follow-up)
- Conditions
- Healthcare Workforce Well-Being
- Being tested
- Engage, HCW-Tailored Engage
- Keywords
- digital mental health interventions, engagement, healthcare workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EngageBehavioural
The digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules. Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking.
HCW-Tailored EngageBehavioural
The digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules. Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking. This version of the intervention contains content tailored specifically for healthcare workers, based on findings from a co-design, qualitative focus group process.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention. Receives: Behavioral: Engage |
| Content Tailoring Group | Experimental | Healthcare-worker-tailored infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention with healthcare worker tailoring. Receives: Behavioral: HCW-Tailored Engage |
| Content Tailoring Plus Human Support Group | Experimental | An onboarding engagement call with a human coach and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention with healthcare worker tailoring, plus human support via messaging (coaching). Receives: Behavioral: HCW-Tailored Engage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with the intervention (subjective)
The primary outcome is engagement with intervention. Subjective engagement will be measured via the TWente Engagement with Ehealth Technologies Scale (TWEETS), a 9-item measure aimed at assessing behavioral engagement, cognitive engagement, and affective engagement. A higher total score reflects a greater, more positive engagement with the digital health intervention.
Measured: From start of intervention to end of intervention period at 6 weeks.
Engagement - Number of Lessons
An objective measure of engagement with the digital intervention is number of lessons read (i.e., module completion). More lessons read reflects more engagement with the intervention.
Measured: From start of intervention to end of intervention period at 6 weeks.
Engagement - Number of Tools
An objective measure of engagement with the digital intervention is number of tools completed (i.e., tool usage). More tools completed reflects more engagement with the intervention.
Measured: From start of intervention to end of intervention period at 6 weeks.
Engagement - Duration of Time
An objective measure of engagement with the digital intervention is the duration of time participants spend on the digital intervention site. More time on the site reflects more engagement with the intervention.
Measured: From start of intervention to end of intervention period at 6 weeks.
Secondary outcomes (3)
Burnout
Burnout is measured via the Oldenburg Burnout Inventory, a validated 16-item survey with positively and negatively framed items that cover 2 areas: exhaustion (physical, cognitive, and affective aspects) and disengagement from work (negative attitudes toward work objects, work content, or work in general). Scores on the Oldenburg Burnout Inventory can be presented as an overall total (range 16 to 64). Higher total scores indicate a higher level of burnout.
Measured: From baseline to follow-up at 10 weeks.
Depressive Symptoms
Depressive symptoms are measured via the Patient Health Questionnaire (PHQ-9), a validated 9-item multipurpose instrument for screening, monitoring, and measuring depression, asking participants to rate their frequency of DSM symptoms over the past 2 weeks. PHQ-9 scores are obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively. Higher scores reflect more depressive symptoms.
Measured: From baseline to follow-up at 10 weeks.
Anxiety symptoms
The Generalized Anxiety Disorder Screener (GAD-7) is a validated 7-item practical self-report anxiety questionnaire, asking participants to rate their frequency of symptoms over the past 2 weeks. GAD-7 score obtained by adding score for each question (total points). Total scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety. Higher scores reflect more anxiety.
Measured: From baseline to follow-up at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare Workforce Well-BeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791563
- Sponsor's protocol ID
- 2025-0594
- Other IDs
- UM1TR005438
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Sustained Engagement in Digital Mental Health Interventions (DMHIs)
- ClinicalTrials.gov ID
- NCT07791563
- Acronym / sponsor ID
- 2025-0594
- Conditions
- Healthcare Workforce Well-Being
- Keywords
- digital mental health interventions, engagement, healthcare workers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test which engagement strategies lead to more participation in a digital mental health program among healthcare workers. The main questions it aims to answer is:
- Does content tailoring increase engagement with the digital program?
- Does human support increase engagement with the digital program?
Researchers will compare the general intervention to a tailored intervention and to the tailored intervention with human support coaching to see what leads to more engagement with/use of the program.
Participants will:
- Use a digital program weekly for 6 weeks
- Complete questionnaires at 5 times: Start of study, Week 2, Week 3 (mid-program), Week 6 (end of program), and Week 10 (follow-up)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: EngageInfographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention. |
| Content Tailoring Group | Experimental | Behavioral: HCW-Tailored EngageHealthcare-worker-tailored infographic onboarding and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention with healthcare worker tailoring. |
| Content Tailoring Plus Human Support Group | Experimental | Behavioral: HCW-Tailored EngageAn onboarding engagement call with a human coach and the Cognitive Behavioral Therapy (CBT)-based 6-week digital mental health intervention with healthcare worker tailoring, plus human support via messaging (coaching). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older, all sexes
- Currently working in healthcare in the US with at least 4 hours per week of direct patient contact
- Stable access to internet
- Have a total score between 3-14 on the PHQ-9 (Patient Health Questionnaire-9), suggestive of mild to moderate depressive symptoms
Key exclusion criteria (3 listed)
- Have a total score of ≥15 on the PHQ-9, indicating Severe Depressive symptoms.
- Currently diagnosed with a psychotic disorder or bipolar disorder, based on self-report.
- Currently receiving psychotherapy for depression or anxiety based on self-report; If on medications for depression or anxiety, must be on a stable dose of medication for at least 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EngageThe digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules. Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking. | Behavioural | Control Group |
| HCW-Tailored EngageThe digital mental health intervention is based on Cognitive Behavioral Therapy principles and consists of learning modules covering basic skills (e.g., behavioral activation) and interactive tools to assist in learning and implementing the skills associated with the learning modules. Interactive tools are designed to support implementation of cognitive behavioral skills including activity scheduling and monitoring, cognitive restructuring, goal setting, relaxation, and mood tracking. This version of the intervention contains content tailored specifically for healthcare workers, based on findings from a co-design, qualitative focus group process. | Behavioural | Content Tailoring Group, Content Tailoring Plus Human Support Group |
Primary outcome
Engagement with the intervention (subjective)
Time frame: From start of intervention to end of intervention period at 6 weeks.
The primary outcome is engagement with intervention. Subjective engagement will be measured via the TWente Engagement with Ehealth Technologies Scale (TWEETS), a 9-item measure aimed at assessing behavioral engagement, cognitive engagement, and affective engagement. A higher total score reflects a greater, more positive engagement with the digital health intervention.
Engagement - Number of Lessons
Time frame: From start of intervention to end of intervention period at 6 weeks.
An objective measure of engagement with the digital intervention is number of lessons read (i.e., module completion). More lessons read reflects more engagement with the intervention.
Engagement - Number of Tools
Time frame: From start of intervention to end of intervention period at 6 weeks.
An objective measure of engagement with the digital intervention is number of tools completed (i.e., tool usage). More tools completed reflects more engagement with the intervention.
Engagement - Duration of Time
Time frame: From start of intervention to end of intervention period at 6 weeks.
An objective measure of engagement with the digital intervention is the duration of time participants spend on the digital intervention site. More time on the site reflects more engagement with the intervention.
3 secondary outcomes
Burnout
Time frame: From baseline to follow-up at 10 weeks.
Depressive Symptoms
Time frame: From baseline to follow-up at 10 weeks.
Anxiety symptoms
Time frame: From baseline to follow-up at 10 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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FLOAT for Healthcare PTSS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage and HCW-Tailored Engage in people with Healthcare Workforce Well-Being, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Duffecy, PhD (312-413-1225, jduffecy@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with the intervention (subjective) (time frame: From start of intervention to end of intervention period at 6 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.